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Sapropterin for BH4 Deficiency Initial and Continuing PBS Authority Application Form

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Sapropterin for BH4 Deficiency Initial and Continuing PBS Authority Application Form

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hello Ellie Reynolds here from the team at Proxima clinical research today we're going over pre- submissions and how they fit into your journey for FDA approval so what exactly is a presubmit [Music] prubs are a part of the Q submission program they allow a sponsor or manufacturer to obtain FDA feedback on specific topics such as a regulatory pathway or study designs prior to an intended pre-market submission during this Q submission time the sponsor submits information and materials to the FDA in the form of a request for feedback that is delivered in what's known as a pre-submission meeting the primary advantage of this process is the chance to engage with FDA early on and receive critical feedback and guidance before formally submitting your application such as a 510k PMA or denovo this proactive approach streamlines the review process minimizing potential delays or setbacks the pre-submission process begins with medical device developers submitting a meeting request

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